Biohaven

The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid

The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.

The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).

The purpose of this study is to test the potential benefits of BHV-7000 in reducing chronic pain in participants with IEM with a previously demonstrated gain of function mutation in the SCN9A gene.

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.

This trial will study the efficacy and safety of taldefgrobep alfa as an adjunctive therapy for participants who are already taking a stable dose of nusinersen and/or risdiplam and/or have a history of onasemnogene abeparvovec, compared to placebo.

Biohaven has programs in 3 areas, and the immunology degraders are the largest and most advanced.

Immunology (degraders that remove disease-driving antibodies): BHV-1300 is in Phase 3 for Graves' disease, first patient enrolled June 2026. On October 8, 2026 Biohaven licensed BHV-1300 and 2 follow-on degraders to Ono Pharmaceutical for Japan, South Korea, Taiwan and Southeast Asia, for $80 million upfront, a $20 million milestone it expects within a year and royalties of about 20% on sales there; Biohaven keeps the rights in the US, Europe and China. BHV-1400 is heading into its pivotal trial for IgA nephropathy, which Biohaven said on October 29, 2026 it expects to start in the fourth quarter of 2026. Earlier degraders are BHV-1450 for IgG4-driven diseases such as pemphigus vulgaris, BHV-1600 for peripartum cardiomyopathy and BHV-1420 for membranous nephropathy.

Brain: opakalim (BHV-7000) is in Phase 2/3 for focal epilepsy, with a partial clinical hold since September 4, 2026. BHV-8000 is in Phase 2/3 for early Parkinson's disease.

Cancer: BHV-1510 and BHV-1530, 2 antibody-drug conjugates, are in early trials for solid tumors, a Phase 1/2 for BHV-1510 and a Phase 1 for BHV-1530, both tested with Regeneron's Libtayo.

Source: Biohaven third quarter 2026 update, October 29, 2026, Biohaven second quarter 2026 update, August 2026, Biohaven on the Ono license, October 8, 2026 and the Biohaven pipeline page.

Troriluzole for spinocerebellar ataxia, the only Biohaven drug under FDA review as of October 22, 2026. A decision is expected in the first quarter of 2027.

Troriluzole for spinocerebellar ataxia: the FDA turned it down on November 4, 2025. Biohaven said on October 22, 2026 that the FDA accepted a resubmitted application for review. Acceptance is not approval, and the FDA plans to ask an outside advisory committee for input.

BHV-1300 for Graves' disease: the only Biohaven degrader in Phase 3. The trial (NCT07661056) enrolled its first patient in June 2026 after early studies cut the thyroid-stimulating antibody by about 80% by week 12, and Biohaven said on November 5, 2026 that more than 55 sites were enrolling in the US and Canada.

Opakalim for focal epilepsy: the RISE 3 pivotal study finished enrolling, with topline results expected in the second half of 2026, but the FDA placed the program on a partial clinical hold on September 4, 2026.

Source: NeurologyLive on the resubmission, October 22, 2026, Biohaven Phase 3 start announcement, June 29, 2026, the second quarter 2026 update and Biohaven on the Phase 3 Graves' trial, November 5, 2026.

The FDA declined to approve it on November 4, 2025, and it is now back under FDA review. Biohaven said on October 22, 2026 that the FDA accepted a resubmitted application, with a decision expected in the first quarter of 2027.

What the FDA said: the main study compared 3 years of treatment against a separate database of untreated patients rather than a placebo group in the same trial. The FDA's published letter says that comparison was not an adequate and well-controlled study. It pointed to overlap between the trial's sites and the database's sites, year 3 scores missing for 52% of treated patients and 79% of the comparison group, and an analysis plan written after Biohaven had already seen earlier results. It concluded that substantial evidence of effectiveness has not been established. The study's earlier 48-week placebo-controlled phase had missed its main goal.

What Biohaven did: cut research spending by about 60%, said it was formally requesting a meeting with the FDA, and kept its expanded access program listed as available on ClinicalTrials.gov, though an ataxia specialist told a Senate committee in February 2026 that the program was about to end. Biohaven had already withdrawn its European application in March 2025, and troriluzole still does not appear on Biohaven's pipeline page.

What happens now: Biohaven says the resubmission adds new positive supportive analyses. The FDA treats it as a complete response to the 2025 letter and plans to convene an advisory committee of outside experts, with no date announced yet. Acceptance is not approval, and the FDA will decide in early 2027.

What patients can do: the troriluzole page and the FDA calendar entry track any FDA news, and the spinocerebellar ataxia page lists every recruiting trial.

Source: NeurologyLive on the resubmission, October 22, 2026, FDA Complete Response Letter, NDA 210862, November 4, 2025, Biohaven on the Complete Response Letter, November 2025 and our post on what the decision means for SCA patients.

A degrader removes a harmful antibody from the blood instead of blocking it.

How it works: the drug grabs a specific antibody or protein and routes it to the liver's natural disposal system, so the antibody is gone rather than muffled. The technology, called MoDE and TRAP, was licensed from Yale.

Why it matters: in people with IgA nephropathy, BHV-1400 lowered the faulty Gd-IgA1 antibody by more than 60% on average within 48 hours and by 70% within a month, with no clinically significant drop in other antibodies.

Scale: nearly 200 people have been dosed across the platform, and Biohaven builds a separate degrader for each disease by changing what the drug grabs.

Source: Biohaven patient biomarker data, May 27, 2026 and the second quarter 2026 update for the number dosed.

Opakalim is in pivotal trials, on a partial clinical hold, and being handed to a partner.

What it is: a once-daily pill that activates Kv7 potassium channels to calm the abnormal firing behind focal seizures.

Trials: 2 Phase 2/3 studies, RISE 2 and RISE 3, in adults whose seizures are not controlled on 1 to 3 medicines; RISE 3 results are expected in the second half of 2026.

Hold: the FDA placed the program on a partial clinical hold on September 4, 2026. BioPharma Dive reported on September 10, 2026 that new patients cannot enroll while people already in the trials keep taking the drug. Biohaven said on October 29, 2026 that the hold remains while it completes more animal studies, with data expected in the coming weeks, and that RISE 3 results are still expected in the second half of 2026.

Deal: on August 26, 2026 Biohaven licensed its Kv7 platform, including opakalim, to SK Biopharmaceuticals for $350 million when the deal closes and $50 million in 2027, plus up to $150 million in development and regulatory milestones and royalties. SK also takes on up to $245 million that Biohaven owes Knopp Biosciences and others for the Kv7 programs, which brings the headline value to $795 million, with SK taking over costs and commercialization once the deal closes. The US antitrust waiting period ended on October 28, 2026, and Biohaven said on October 29 that it looks forward to closing.

Source: the Biohaven third quarter 2026 update, October 29, 2026, and the opakalim drug page carries the FDA and Biohaven sources for each earlier point.

No. It missed the main goal of its Phase 3 trial in November 2024.

The trial: RESILIENT (NCT05337553) gave patients aged 4 to 21, in 9 countries, a weekly injection of taldefgrobep or placebo on top of their regular SMA drug for 48 weeks.

The result: no significant improvement on the motor scale it was built to move.

What now: Biohaven moved the drug into obesity, where the goal is weight loss that spares muscle; the Phase 2 study finished enrolling in early 2026. Biohaven said on October 29, 2026 that the study is being amended to add a part combining the drug with a GLP-1-based medicine, and that results for both parts are now expected in the second half of 2027.

Source: Biohaven update on taldefgrobep alfa, November 2024, the Biohaven third quarter 2026 update, October 29, 2026 and the taldefgrobep page.

Not anymore. There have been 2 Biohavens.

The first: developed the migraine pill Nurtec ODT and was bought by Pfizer for $11.6 billion in 2022. Pfizer kept Nurtec.

The second: founder and CEO Vlad Coric spun the rest of the pipeline out as a new public company in October 2022. It trades on the NYSE as BHVN, is based in New Haven, Connecticut, and is the company on this page.

The live list on this page comes straight from ClinicalTrials.gov; as of November 2026 these are the ones that matter most for rare disease patients.

Graves' disease: the Phase 3 BHV-1300 study (NCT07661056) and a Phase 1 study in adults with Graves' disease (NCT06980649). An open-label Phase 2b/3 safety study (NCT07901244) is registered but not yet recruiting.

IgA nephropathy: a Phase 1 BHV-1400 study (NCT07054684) is recruiting. Biohaven's pivotal Phase 3 BHV-1400 trial (NCT07642050) is registered but not yet recruiting, and Biohaven said on October 29, 2026 that it expects to open it in the fourth quarter of 2026.

Each disease page on Trial Friend shows eligibility rules and site locations, and Match Me checks your details against every open trial.

None as of November 2026. Biohaven has no FDA-approved drug yet; the FDA is reviewing its most advanced program.

Most advanced: Vyglxia (under FDA review), BHV-1300 (Phase 3), Opakalim (on clinical hold), BHV-1400 (Phase 1).

Where to watch: the FDA calendar lists any Biohaven application once a decision date is public, and the trials list on this page shows what is recruiting now.